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Dual CD33-CLL1-CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

NCT05016063 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-08-23

No results posted yet for this study

Summary

Phase I, interventional, single-arm, open-label, treatment study to evaluate the safety and effectiveness of CD33-CLL1 CAR in patients with relapsed and/or refractory acute myeloid leukemia (AML).

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

Fludarabine

recommendation: 30mg/m2 (D-5\~D-3),determined by tumor burden at baseline.

DRUG

Cytoxan

recommendation: 300-500mg/m2 (D-5\~D-3),determined by tumor burden at baseline.

BIOLOGICAL

Dual CD33-CLL1 CAR-T cells

CD33-CLL1 CAR-T infusion (starting at dose level 1 \[DL1\]: 0.5 x 106 transduced CAR-T cells/kg) on Day 0.

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Xinqiao Hospital of Chongqing

    lead OTHER

Principal Investigators

  • xi zhang, PhD/MD · Department of Hematology, Xinqiao Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-09-01
Completion
2023-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05016063 on ClinicalTrials.gov